Blood vessel plugging and flow transferring device and medical equipment

Abstract

The invention discloses a blood vessel blocking and flow transferring device and medical equipment, and relates to the technical field of medical equipment, and the blood vessel blocking and flow transferring device comprises a catheter, a blocking piece, an expandable balloon and a fluid pump. Two ends of the catheter are respectively placed into two incisions of the blood vessel, and the catheter is used for communicating blood of the two incisions of the blood vessel; the blocking piece is arranged on the catheter, and the blocking piece is used for blocking the catheter in a first state and opening the catheter in a second state; the expandable balloons are arranged at the two ends of the catheter, and the balloons are used for being placed into a blood vessel through an incision so as to fix the catheter to the blood vessel and further used for taking out obstructions from the blood vessel; the fluid pump is communicated with the balloon, and the fluid pump is used for injecting fluid into the balloon, so that the balloon is in a preset expansion state. According to the blood vessel blocking and flow turning device, the problem that in the prior art, function integration of precise blocking, temporary flow turning and synchronous thrombus taking cannot be achieved in the same device is solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a blood vessel occlusion and shunt device and a medical device. BACKGROUND

[0002] At present, the exogenous recanalization surgery for important blood vessel obstruction is the main way to treat thrombus, cancer embolus or iatrogenic foreign bodies (such as broken catheters, displaced filters, etc. that cannot be removed in interventional surgery). Such surgery needs to be performed under open or hybrid surgery conditions, and the core link is that during the operation of removing the obstruction, temporary blood flow occlusion of the target blood vessel must be implemented. For example, in the Mayo II level inferior vena cava cancer embolus resection surgery, the inferior vena cava distal and proximal ends, the healthy side renal artery, and multiple in-flowing vessels such as the affected renal vein, lumbar vein, and adrenal central vein need to be sequentially occluded; some complex cases even need to occlude the first hepatic portal to control the return of blood volume. The technical necessity of this occlusion measure is to prevent the obstruction from falling off and causing distal embolism, and to provide a clear operation field for the surgery. However, the existing technology faces technical contradictions, including:

[0003] First, the positive correlation between ischemic injury risk and operation difficulty: when the obstruction is closely adhered to the blood vessel wall, has a large volume or an irregular shape, the separation and removal process is significantly prolonged. Important organs (such as the liver, kidneys, and spinal cord) have limited tolerance to ischemia, and if the occlusion time exceeds the safe threshold, it will directly lead to irreversible cell damage, organ dysfunction, and even necrosis. In clinical practice, a considerable proportion of cases of postoperative liver failure, acute kidney injury, and other serious complications are caused by prolonged occlusion time due to difficulty in removing the embolus.

[0004] Second, the inherent defects of extracorporeal bypass shunt: To alleviate ischemic problems, some surgical procedures use extracorporeal circulation or bypass catheterization to establish a temporary blood passage. However, this scheme requires additional vascular puncture or incision catheterization, increasing the risk of surgical trauma and vascular injury, and the long infusion pipeline is prone to clotting. In addition, the operation process inevitably wastes effective circulating blood volume, posing an additional risk to patients with low blood volume.

[0005] Therefore, how to avoid the technical problem that the existing technology cannot achieve the functional integration of precise occlusion, temporary shunt, and synchronous embolus removal in the same device, resulting in a technical dilemma between surgical safety and effectiveness, is a technical problem that needs to be solved by those skilled in the art. SUMMARY

[0006] The purpose of the present application is to provide a blood vessel occlusion and shunt device and a medical device, which solves the problem that the existing technology cannot achieve the functional integration of precise occlusion, temporary shunt, and synchronous embolus removal in the same device.

[0007] To achieve the above-mentioned purpose, the present application provides a blood vessel occlusion and shunt device, comprising:

[0008] A catheter having two ends respectively inserted into two incisions of a blood vessel for communicating blood between the two incisions of the blood vessel;

[0009] A blocking member arranged on the catheter for blocking the catheter in a first state and opening the catheter in a second state;

[0010] An inflatable balloon arranged on the two ends of the catheter for being inserted into the blood vessel through the incisions to fix the catheter in the blood vessel and for taking out the obstruction from the blood vessel;

[0011] A fluid pump in communication with the balloon for injecting fluid into the balloon to make the balloon in a preset inflated state.

[0012] In some embodiments, the blocking member comprises a blocking body provided with a through hole for the catheter to pass through, and the blocking body comprises a rigid side wall and an elastic side wall, and the blocking body blocks the catheter when the elastic side wall abuts against the rigid side wall.

[0013] In some embodiments, the blocking member further comprises a connecting structure arranged on the outer wall of the rigid side wall and the elastic side wall, and the connecting structure is used for connecting an operating instrument, and the operating instrument acts on the elastic side wall and the rigid side wall to switch the blocking member from the first state to the second state.

[0014] In some embodiments, the connecting structure is a connecting lug, and the connecting lug forms a lug hole with the outer wall of the elastic side wall or the rigid side wall for the operating instrument to extend into.

[0015] In some embodiments, the two ends of the catheter have elastic sections, and a helical spring skeleton is embedded in the tube wall of the elastic section for preventing the catheter from being bent and occluded at the incisions of the blood vessel.

[0016] In some embodiments, the outer surface of the balloon in the inflated state is in a stepped shape, and the balloon comprises an integral cylindrical fixing part and a tapered scraping part, and the taper angle of the tapered scraping part is 15°-45° for contacting and scraping off the obstruction on the inner wall of the blood vessel.

[0017] In some embodiments, the fluid pump comprises:

[0018] A connecting member in communication with the balloon;

[0019] A balloon body having one end connected with the connecting member for switching between a retracted configuration, a first inflated configuration and a second inflated configuration;

[0020] The valve column is movably embedded in the connecting piece, two ends of the valve column are connected with the first valve and the second valve respectively, the other end of the capsule body is connected with the first valve, and the valve column is configured to switch the capsule body from the retracted configuration to the first inflation configuration in the first movement stage to guide the external fluid into the capsule body through the first valve, and switch the capsule body from the first inflation configuration to the second inflation configuration in the second movement stage to inject the fluid in the capsule body into the balloon through the valve column, the second valve and the connecting piece.

[0021] In some embodiments, the connecting piece is provided with a discharge port, and the valve column is configured to close the discharge port at the end of the first movement stage and the second movement stage, and open the discharge port when being separated from the connecting piece to discharge the fluid in the capsule body and the balloon from the discharge port.

[0022] In some embodiments, the capsule body comprises an elastic framework and a membrane body arranged on the elastic framework, the elastic framework is connected with the connecting piece and the first valve, the membrane body is used to deform under the driving of the elastic framework, and the elastic framework comprises:

[0023] a first connecting ring fixed to the connecting piece;

[0024] a second connecting ring fixed to the first valve;

[0025] a plurality of elastic arms arranged between the first connecting ring and the second connecting ring in the circumferential direction, used to provide an elastic force to the membrane body, so that the capsule body has a tendency to switch from the retracted configuration to the first inflation configuration, or from the second inflation configuration to the first inflation configuration.

[0026] The application also provides a medical device comprising the vascular occlusion and bypass device described in any one of the above.

[0027] With respect to the background art described above, the vascular occlusion and bypass device provided by the embodiments of the application comprises a catheter, a blocking member, an inflatable balloon and a fluid pump. The two ends of the catheter are respectively inserted into two incisions of a blood vessel, and the catheter is used to communicate the blood of the two incisions of the blood vessel; the blocking member is arranged on the catheter, and is used to block the catheter when being in a first state and open the catheter when being in a second state; the inflatable balloon is arranged at the two ends of the catheter, and is used to be inserted into the blood vessel through the incision to fix the catheter to the blood vessel, and is also used to take out the obstruction from the blood vessel; the fluid pump is in communication with the balloon, and is used to inject fluid into the balloon to make the balloon in a preset inflation state.

[0028] In operation, the two ends of the catheter are inserted into different blood vessels or the incisions / broken ends of the distal and proximal ends of the same blood vessel in the body, and are fixed to the blood vessel through the balloon, so as to communicate the blood of the two incisions of the blood vessel. At the same time, when the balloon is of an appropriate size, the balloon can be pulled to perform the operation of taking out the thrombus or cancer embolus.

[0029] The blood vessel blocking and bypass device is an integrated device capable of establishing a physiological blood bypass in a blocking state and removing the blocking object, thereby shortening the effective ischemic time, reducing additional trauma and reducing the risk of blood clotting. Specifically, the blood passage is established by a catheter with a balloon through a blood vessel incision in the body. The blood vessel incision is a step that must be performed by exogenous invasive surgery, so the blood passage established through the blood vessel incision in the body does not cause additional vascular trauma, and the passage is established quickly, simply, and has a shorter passage and a lower blood clotting probability. In addition, the blocking object on the catheter can block the bleeding of the important blood vessels. Furthermore, the fluid pump injects fluid into the balloon to make the balloon in a preset inflated state, which not only fixes the end of the catheter in the blood vessel through the balloon, but also allows the balloon to be dragged to remove thrombus or cancer embolus and the like when the balloon is of an appropriate size, which is simple and has strong versatility and can be applied to laparoscopic and open surgery. BRIEF DESCRIPTION OF DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the related art, the following will briefly introduce the drawings needed to be used in the embodiments or the related art description. Obviously, the drawings in the following description are only embodiments of the present application, and those skilled in the art can obtain other drawings according to the provided drawings without any creative effort.

[0031] Figure 1 The connection diagram of the blood vessel blocking and bypass device in the embodiments of the present application.

[0032] Figure 2 The connection diagram of the blood vessel blocking and bypass device in the embodiments of the present application. Figure 1 The enlarged view of the A part in FIG.

[0033] Figure 3 The connection diagram of the blood vessel blocking and bypass device in the embodiments of the present application. Figure 1 The enlarged view of the B part in FIG.

[0034] Figure 4 The connection diagram of the blood vessel blocking and bypass device in the embodiments of the present application. Figure 1 The enlarged view of the C part in FIG.

[0035] Figure 5 The connection diagram of the blood vessel blocking and bypass device in the embodiments of the present application. Figure 1 The structure diagram of the blocking object in the blood vessel blocking and bypass device shown in FIG.

[0036] Figure 6 The structure diagram of the fluid pump in the blood vessel blocking and bypass device shown in FIG. Figure 1 The structure diagram of the fluid pump in the blood vessel blocking and bypass device shown in FIG. Figure 1 .

[0037] Figure 7 The structure diagram of the fluid pump in the blood vessel blocking and bypass device shown in FIG. Figure 1 The structure diagram of the fluid pump in the blood vessel blocking and bypass device shown in FIG. Figure 2.

[0038] Figure 8 Fig. 4 is a schematic view of the connection between the valve stem, the first valve and the second valve in the fluid pump shown in Fig. 1. Figure 6

[0039] Figure 9 Fig. 5 is a schematic view of the connection between the valve stem, the first valve and the second valve in the fluid pump shown in Fig. 2. Figure 6 Figure 1 .

[0040] Figure 10 Fig. 6 is a schematic view of the connection between the valve stem, the first valve and the second valve in the fluid pump shown in Fig. 3. Figure 6 Figure 2 .

[0041] Figure 11 Fig. 7 is a schematic view of the structure of the first valve in the fluid pump shown in Fig. 4. Figure 9 Figure 1 .

[0042] Figure 12 Fig. 8 is a schematic view of the structure of the first valve in the fluid pump shown in Fig. 5. Figure 9 Figure 2 .

[0043] Figure 13 Fig. 9 is a schematic view of the connection between the valve stem and the second valve in the fluid pump shown in Fig. 6. Figure 9

[0044] Wherein:

[0045] 1 - fluid pump;

[0046] 10 - connecting member, 11 - discharge port;

[0047] 20 - bladder, 21 - elastic framework, 211 - first connecting ring, 212 - second connecting ring, 213 - elastic arm, 22 - membrane;

[0048] 30 - valve stem, 31 - flow-through port;

[0049] 40 - first valve, 41 - first inlet, 42 - first outlet;

[0050] 50 - second valve, 51 - second inlet, 52 - second outlet;

[0051] 2 - conduit;

[0052] 3 - blocking member, 301 - blocking body, 3011 - rigid side wall, 3012 - elastic side wall, 302 - through hole, 303 - connecting structure,

[0053] 4 - balloon. DETAILED DESCRIPTION

[0054] ​​​​​​With reference to the drawings and specific embodiments, the technical solutions in the embodiments of the present application will be described in detail below. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of the present application.

[0055] In order for those skilled in the art to better understand the technical solutions of the present application, the present application will be further described in detail below with reference to the drawings and specific embodiments.

[0056] It should be noted that the "upper end, lower end, left side, right side" and the like described below are defined based on the drawings of the specification.

[0057] Please refer to Figures 1 to 3 The blood vessel occlusion and bypass device provided by the embodiments of the present application comprises a catheter 2, a blocking member 3, an inflatable balloon 4 and a fluid pump 1.

[0058] The two ends of the catheter 2 are respectively inserted into two incisions of a blood vessel, and the catheter 2 is used to communicate the blood of the two incisions of the blood vessel; the blocking member 3 is arranged on the catheter 2, and the blocking member 3 is used to block the catheter 2 when in a first state and open the catheter 2 when in a second state; the inflatable balloon 4 is arranged at the two ends of the catheter 2, and the balloon 4 is used to be inserted into the blood vessel through the incision to fix the catheter 2 in the blood vessel and also used to take out the obstruction from the blood vessel.

[0059] It should be noted that the end of the catheter 2 passes through the corresponding balloon 4 to facilitate the blood flow. When installed, the blocking member 3 is in the first state, at this time, the blocking member 3 blocks the catheter 2 to prevent blood from overflowing out of the blood vessel, and when the installation is completed, the blocking member 3 is in the second state, at this time, the catheter 2 is opened to facilitate the establishment of a blood passage in the body (outside the blood vessel) through the blood vessel incision.

[0060] The fluid pump 1 communicates with the balloon 4, and the fluid pump 1 is used to inject fluid into the balloon 4 to make the balloon 4 in a preset inflated state. The fluid injected by the fluid pump 1 can be gas or liquid (such as normal saline or contrast medium, etc.), and the preset inflated volume of the balloon 4 is accurately controlled by the injection amount of the fluid.

[0061] In operation, the two ends of the catheter 2 are inserted into the incisions / broken openings of different blood vessels or the distal and proximal ends of the same blood vessel in the body, and are fixed in the blood vessel through the balloon 4, thereby communicating the blood of the two incisions of the blood vessel. At the same time, when the balloon 4 is of an appropriate size, the operation of taking thrombus or cancer embolus can be performed by pulling the balloon 4.

[0062] The blood vessel blocking and bypass device thus arranged is an integrated device capable of synchronously establishing a physiological blood bypass while maintaining the blocking state and having the function of removing the blocking object, so as to shorten the effective ischemic time, reduce additional trauma and reduce the risk of blood clotting.

[0063] Specifically, the blood passage is established by forming a blood flow path through the blood vessel incision in the body by the catheter 2 provided with the balloon 4. Since the blood vessel incision is a step that must be performed by exogenous invasive surgery, the method of establishing the blood passage in the body through the blood vessel incision does not cause additional vascular trauma, and the passage is established quickly, simply, and has a shorter passage and a lower probability of blood clotting. At the same time, the blocking member 3 on the catheter 2 can block the bleeding of the important blood vessels. In addition, the fluid pump is used to inject fluid into the balloon 4 to make the balloon 4 in a preset inflated state, which not only can fix the end of the catheter 2 in the blood vessel by the balloon 4, but also can drag the balloon 4 to remove thrombus or cancer embolus and the like when the balloon 4 is of an appropriate size, which is simple and has strong versatility and can be applied to laparoscopic and open surgery.

[0064] It should be emphasized that for the removal of cancer embolus in the inferior vena cava and the like, the current method must use an exogenous surgery to place a urinary catheter with an inflated balloon in the blood vessel, or use a method of puncturing the femoral vein to intervene and place a balloon. The urinary catheter is relatively thick, which increases the risk of cancer embolus falling off. The femoral vein puncture has a certain trauma, and the blood must be stopped after the catheter is pulled out, which is more likely to cause thrombosis. The method of directly placing a relatively thin catheter 2 in the blood vessel breakage and inflating the balloon 4 in the exogenous invasive surgery can reduce related complications.

[0065] Please refer to Figure 4 and Figure 5 The blocking member 3 is arranged outside the catheter 2, and the blocking member 3 includes a blocking body 301 provided with a through hole 302 for the catheter 2 to pass through. The blocking body 301 includes a hard sidewall 3011 and an elastic sidewall 3012. When the elastic sidewall 3012 abuts against the hard sidewall 3011, the blocking body 301 blocks the catheter 2.

[0066] Specifically, the blocking body 301 is an integrated structure. When the blocking body 301 is in the second state, the blocking body 301 is in an oval or "O" shape. The blocking body 301 has two side surfaces, one of which is hard and the other of which is flexible and elastic. The outer side surfaces of the two side surfaces are respectively provided with a connecting structure. When pressed, the elastic side abuts against the hard side, and the venous catheter 2 remains in the clamped and blocked state after the pressure is removed.

[0067] In some embodiments, the blocking member 3 further comprises a connecting structure 303, which is arranged on the outer wall of the elastic side wall 3012 and the rigid side wall 3011, and is used to connect an operating instrument that acts on the elastic side wall 3012 and the rigid side wall 3011 to switch the blocking member 3 from the first state to the second state.

[0068] For example, the connecting structure 303 is a connecting ear, which forms an ear hole with the outer wall of the elastic side wall 3012 or the rigid side wall 3011, for the operating instrument to extend into.

[0069] When the two sides of the blocking body 301 are separated by extending the operating instrument into the connecting ear, the blocking body 301 restores to an oval or "O" shape, at which time the venous catheter 2 remains in an open state.

[0070] In some embodiments, the two ends of the catheter 2 have elastic sections, and a spiral spring skeleton is embedded in the tube wall of the elastic section, which is used to prevent the catheter 2 from being bent and occluded at the blood vessel incision.

[0071] In this way, a spiral spring structure is embedded in the tube wall of the elastic section, and the spring skeleton provides additional support and flexibility, so that the catheter 2 is not easy to bend when subjected to external force. Considering that at the blood vessel incision, the catheter 2 may be bent due to the contraction of the blood vessel or the extrusion of external force, causing the internal passage of the catheter 2 to be occluded and affecting blood flow. The spiral spring skeleton helps the catheter 2 to remain open by its elasticity and support, ensuring the smooth progress of medical operations.

[0072] In some embodiments, the outer surface of the balloon 4 in the inflated state is stepped, and the balloon 4 comprises an integral cylindrical fixed part and a tapered scraping part, and the taper angle of the tapered scraping part is 15°-45°, which is used to contact and scrape off the blockage on the inner wall of the blood vessel.

[0073] It should be noted that the outer surface of the balloon 4 in the inflated state is stepped, which means that the outer surface of the balloon 4 is not smooth, but has a multi-stage boss or ring structure, forming a geometric shape similar to "steps". This design helps to increase the contact area with the blood vessel wall, provide a local high-pressure point, enhance the effect of scraping or peeling off the blockage, and at the same time prevent the balloon 4 from sliding in the blood vessel, improve the operation stability. Among them, the cylindrical fixed part provides stable support and positioning function, usually connected with the catheter body, to ensure that the position of the balloon 4 is fixed when inflated; the tapered scraping part is in a tapered structure, which is used to contact and scrape off the blockage on the inner wall of the blood vessel, and the tapered scraping part is integrally formed with the cylindrical part (without joint), which improves the strength and safety, and avoids the risk of falling off.

[0074] In addition, the taper angle (i.e. the angle between the tapered generatrix and the axis) is controlled to be between 15° and 45°, which is an optimized range for effective shaving and vascular safety.

[0075] Of course, according to actual needs, the outer surface of the tapered shaving portion can also be provided with helical or annular raised edges, and the height of the raised edges is 0.1mm-0.5mm.

[0076] In addition, the device also includes a sealing sleeve, which is sleeved on the outer wall of the catheter 2 and is adjacent to the balloon 4, and is composed of an everted skirt film and a tightening band, for sealing the gap between the catheter 2 and the vascular incision.

[0077] Please refer to Figure 6 and Figure 7 The fluid pump 1 provided by the embodiment of the present application comprises a connecting piece 10, a balloon body 20 and a valve column 30.

[0078] The connecting piece 10 is in communication with the corresponding balloon 4 through a pipeline, so that the balloon body 20 is in communication with the corresponding balloon 4.

[0079] One end of the balloon body 20 is connected with the connecting piece 10, and the other end of the balloon body 20 is connected with a first valve 40 located at the first end of the valve column 30, and the balloon body 20 is used for switching between a retracted configuration, a first inflation configuration and a second inflation configuration. In the process of switching the balloon body 20 from the retracted configuration to the first inflation configuration, external fluid can be introduced into the balloon body 20 through the first valve 40, and in the process of switching the balloon body 20 from the first inflation configuration to the second inflation configuration, the fluid in the balloon body 20 can be injected into the corresponding balloon 4 through the valve column 30, the second valve 50 and the connecting piece 10.

[0080] The fluid pump 1 can work with the carbon dioxide gas filled in the laparoscopic (including robotic) surgery, without the need to find another liquid to pump in, and the application condition is simple.

[0081] The so-called retracted configuration refers to the initial state of the balloon body 20, and the balloon body 20 in the initial state is in a completely compressed state (or completely collapsed) in the radial direction. The first inflation configuration refers to the spherical state of the balloon body 20, and in the process of switching the balloon body 20 from the retracted configuration to the first inflation configuration, the balloon body 20 is in a negative pressure state, and the working medium (generally fluid) in the external environment enters the balloon body 20 to make it full. The second inflation configuration refers to the configuration (which can be understood as an ellipsoidal configuration) reached after the balloon body 20 in the first inflation configuration is axially compressed, and when the balloon body 20 in the first inflation configuration is axially compressed, the balloon body 20 is switched from the first inflation configuration to the second inflation configuration, so that the fluid in the balloon body 20 flows into the balloon 4, and the balloon 4 reaches the working state after being filled with the fluid.

[0082] The valve stem 30 is movably or slidably embedded in the connector 10, and is movable along the axial direction of the connector 10 relative to the connector 10, and is embeddable or disembeddable in the connector 10. The valve stem 30 is connected with the first valve 40 and the second valve 50 at two ends thereof respectively, and the outlet end of the first valve 40 and the inlet end of the second valve 50 are tightly connected through the valve stem 30.

[0083] The valve stem 30 is configured to switch the capsule 20 from the retracted configuration to the first inflation configuration in the first movement stage to guide the external fluid into the capsule 20 through the first valve 40, and to switch the capsule 20 from the first inflation configuration to the second inflation configuration in the second movement stage to inject the fluid in the capsule 20 into the balloon 4 through the valve stem 30, the second valve 50 and the connector 10. The first movement stage and the second movement stage are two different stages in one driving action of the valve stem 30 respectively.

[0084] It should be noted that the first valve 40 and the second valve 50 are both diaphragm type one-way valve bodies, and each contains a circular rubber diaphragm inside, which is movable in the cylindrical cavity of the valve body to realize the one-way flow of fluid in the valve body.

[0085] Compared with the prior art which relies on an external syringe, a three-way valve and an extension pipeline to realize balloon inflation, the embodiment of the present application integrates the function of controlling the expansion of the balloon 4 entirely inside the fluid pump 1: the connector 10 is directly connected to the corresponding balloon 4 through the pipeline, the capsule 20-valve stem 30-double valve forms a closed-loop fluid passage, and the capsule 20 can complete the whole process of "liquid absorption-pressurization-injection" among the three configurations of retraction, first inflation and second inflation by one-time driving of the valve stem 30, so that the power transmission path is short and the energy loss is small, the inflation speed and pressure accuracy are significantly improved, and at the same time, the fluid pump 1 can directly enter the laparoscope channel without external needle cylinder, three-way or extension pipe, so that the extra channel occupation and visual field influence are completely eliminated, and the trauma risk caused by additional cannula is reduced.

[0086] In order to facilitate the fluid flow after the work is completed, the connector 10 is provided with a discharge outlet 11, and the valve stem 30 is configured to close the discharge outlet 11 at the end of the first movement stage and the second movement stage, and open the discharge outlet 11 when disengaged from the connector 10 to discharge the fluid in the capsule 20 and the balloon 4 from the discharge outlet 11.

[0087] It should be noted that the first movement stage of the valve stem 30 mainly includes the stage when the valve stem 30 has not been inserted into the connector 10 and the stage when the valve stem 30 is inserted into the connector 10 and closes the discharge outlet 11 (i.e. the end of the first movement stage). In other words, the valve stem 30 starts to be inserted into the connector 10 and close the discharge outlet 11 at the end of the first movement stage.

[0088] In this way, when liquid needs to be sucked, the capsule 20 is switched from the retracted configuration to the first inflation configuration to introduce the fluid in the external environment into the capsule 20 through the first valve 40; when liquid needs to be injected, the capsule 20 is switched from the first inflation configuration to the second inflation configuration to inject the fluid in the capsule 20 into the corresponding balloon 4 through the valve column 30, the second valve 50, the connecting piece 10 and the pipeline; after repeatedly axially compressing the capsule 20 and removing the compression factor, the fluid in the external environment can be continuously pumped into the balloon 4 through the capsule 20 and the balloon 4 enters the working state. When liquid needs to be discharged after work, the capsule 20 is radially compressed (which can be achieved by the axial movement of the valve column 30), and the fluid in the balloon 4 and the fluid in the capsule 20 flow into the external environment, so that the entire device and the balloon 4 are empty again and return to the initial state. At this time, the overall device can end work and be taken out of the working environment.

[0089] For example, the connecting piece 10 is provided with a plurality of discharge ports 11 distributed in the circumferential direction at the end close to the capsule 20, so that the fluid in the balloon 4 and the fluid in the capsule 20 can flow out to the external environment through the discharge ports 11.

[0090] In order to facilitate connection with the pipeline, the end of the connecting piece 10 away from the capsule 20 is a tapered end (forming a thin end), and the inner diameter of at least part of the structure of the tapered end is tapered away from the capsule 20. In this way, the tapered end not only facilitates the connection of the pipeline, but also forms an inner cavity for the valve column 30 to move in the first movement stage and the second movement stage.

[0091] That is, the non-tapered part of the connecting piece 10 is the part that moves with the valve column 30, and the valve column 30 is movably embedded in this part, which not only guides the movement of the valve column 30, but also limits the stroke of the valve column 30, so that the movement of the valve column 30 is within the set range.

[0092] Please refer to Figure 8 , the capsule 20 includes an elastic framework 21 and a membrane 22 (which can be a tough film).

[0093] The elastic framework 21 is connected with the connecting piece 10 and the first valve 40; the membrane 22 is arranged on the elastic framework 21, and the membrane 22 is deformed under the driving of the elastic framework 21.

[0094] In the embodiment, the elastic skeleton 21 comprises a first connecting ring 211, a second connecting ring 212, and a plurality of elastic arms 213. The first connecting ring 211 is fixed to the connecting member 10, the second connecting ring 212 is fixed to the first valve 40, and the plurality of elastic arms 213 are arranged between the first connecting ring 211 and the second connecting ring 212 in the circumferential direction, and are used to provide elastic force to the membrane body 22, so that the capsule 20 has a tendency to switch from the retracted configuration to the first inflated configuration, or from the second inflated configuration to the first inflated configuration.

[0095] In this way, the elastic arms 213 are uniformly distributed in the circumferential direction, so that the membrane body 22 is uniformly supported in the radial direction throughout the circumference, reducing local stress concentration, prolonging the fatigue life of the membrane body 22, while ensuring the geometric accuracy of the spherical state, reducing flow pulsation. In addition, the first connecting ring 211 and the second connecting ring 212 are rigidly fixed to the connecting member 10 and the first valve 40 respectively, forming two-point positioning, which not only facilitates rapid assembly, but also ensures that the elastic skeleton 21 and the membrane body 22 are coaxial, avoiding asymmetric deformation caused by deflection.

[0096] It should be noted that the capsule 20 structure composed of the elastic skeleton 21 and the membrane body 22 is in a stable state in the first inflated configuration (spherical state), in other words, when in the retracted configuration or the second inflated configuration, the capsule 20 is in an unstable state and has a tendency to recover or switch to the first inflated configuration. The beneficial effects brought by such an arrangement include at least the following aspects:

[0097] Firstly, whether the capsule 20 is excessively stretched axially to the retracted configuration or compressed axially to the second inflated configuration, all the elastic arms 213 will generate a restoring force directed to the spherical state, achieving "automatic return". This feature can prevent the membrane body 22 from collapsing, folding or being excessively tensioned when the system loses pressure or stops, significantly improving reliability.

[0098] Secondly, the first inflated configuration is the stable equilibrium state, and the retracted and second inflated configurations are potential energy high points. Only one charging / discharging pressure action is needed to predict the direction of movement of the capsule 20, simplifying the control algorithm and reducing the number of sensors and logical complexity.

[0099] Thirdly, the spherical stable state has the smallest surface area under the same volume, reducing the overall outer diameter; in the retracted or second inflated configuration, the folding / extension action of the elastic arms 213 is completed in the axial direction, without additional radial dimension, which is suitable for compact space applications.

[0100] Fourthly, the membrane body 22 in the spherical state has an ideal linear relationship between tension and internal pressure, which can be used with a pressure sensor to obtain high-precision real-time diameter monitoring through simple calibration, improving the measurement and control accuracy of the system.

[0101] Please refer to Figures 9 to 13 The first valve 40 and the second valve 50 are both diaphragm type one-way valves, and each contains a circular rubber diaphragm inside, which can move in the cylindrical cavity of the valve body to achieve one-way flow of fluid in the valve body. Specifically, the first valve 40 is provided with a first inlet 41 at the end away from the valve column 30, and the side of the first inlet 41 close to the valve column 30 is provided with a first outlet 42 arranged in the circumferential direction, so that external fluid enters the first valve 40 through the first inlet 41 and enters the capsule 20 through the first outlet 42; the valve column 30 is provided with a flow passage 31 at the end close to the first valve 40, the flow passage 31 is used to connect the capsule 20 and the valve column 30, and the second valve 50 is provided with a second inlet 51 at the end close to the valve column 30, and the side of the second inlet 51 away from the valve column 30 is provided with a second outlet 52 arranged in the circumferential direction, so that the fluid entering the valve column 30 from the capsule 20 enters the second valve 50 through the second inlet 51 and enters the connecting piece 10 through the second outlet 52.

[0102] When the elastic framework 21 is in the normal state (first inflation configuration) or the state of being axially compressed and radially expanded (second inflation configuration), the front end of the valve column 30 and the second valve 50 are inserted into the connecting piece 10, and the valve column 30 closes the side fluid passage (discharge outlet 11) of the connecting piece 10. When the elastic framework 21 changes from the normal state (first inflation configuration) to the state of being axially compressed and radially expanded (second inflation configuration), under the action of fluid pressure, the diaphragm of the first valve 40 moves from the outlet end to the inlet end and closes the latter, and fluid cannot flow out of the capsule 20 through the first valve 40 outlet end into the external environment; and the diaphragm of the second valve 50 moves from the inlet end to the outlet end, and fluid enters the balloon 4 from the capsule 20.

[0103] When the elastic framework 21 recovers from the fully radially compressed and axially expanded state (retracted configuration) to the normal state (first inflation configuration), the valve column 30 has not yet been inserted into the connecting piece 10 and closed the side fluid passage (discharge outlet 11) of the connecting piece 10, and the side fluid passage (discharge outlet 11) of the connecting piece 10 is open, under the action of fluid pressure, fluid can enter the capsule 20 through the side fluid passage (discharge outlet 11) of the connecting piece 10. At the same time, under the action of fluid pressure, the diaphragm of the first valve 40 moves from the inlet end to the outlet end, and fluid also enters the capsule 20 from the external environment through the inlet end of the first valve 40. After the valve column 30 is inserted into the connecting piece 10 and closes the side fluid passage (discharge outlet 11) of the connecting piece 10, under the action of fluid pressure, the diaphragm of the first valve 40 is still located at the outlet end, and fluid continues to enter the capsule 20 from the external environment through the inlet end of the first valve 40.

[0104] When the elastic skeleton 21 starts to expand axially and compress radially from the normal shape (first inflation configuration), the valve column 30 is pulled out of the connecting piece 10, the side fluid passage (discharge port 11) of the connecting piece 10 is restored to be unobstructed, and the fluid in the balloon 4 and the fluid in the balloon body 20 are both discharged through the side fluid passage (discharge port 11) of the connecting piece 10 into the external environment.

[0105] In some embodiments, the fluid pump 1 further comprises a pressure sensor and a display device. The pressure sensor is arranged in fluid communication with the balloon body 20, and is configured to detect the inflation pressure inside the balloon body 20 in real time and output a corresponding inflation pressure signal. The display device is connected to the pressure sensor and is configured to display the diameter of the balloon body 20 under the inflation pressure in real time according to the inflation pressure signal fed back by the pressure sensor.

[0106] In this embodiment, the display device comprises a receiving module, a signal conversion module, and a display module. The receiving module is configured to receive the inflation pressure signal fed back by the pressure sensor. The signal conversion module is connected to the receiving module and is configured to convert the inflation pressure signal fed back by the pressure sensor into an inflation pressure-time curve. The display module is connected to the signal conversion module and is configured to identify the switching of the balloon body 20 between the retracted configuration, the first inflation configuration, and the second inflation configuration according to the inflation pressure-time curve, and to extract the inflation pressure peak value in the inflation pressure-time curve and calculate and display the diameter of the balloon body 20 in real time based on a preset inflation pressure-diameter correspondence relationship.

[0107] It should be noted that the display module takes the pressure curve as an "identity fingerprint". The specific process is as follows: first, the curve shape is observed to identify whether the balloon body 20 is in the retracted configuration, the first inflation configuration, or the second inflation configuration; second, the highest point of the curve is found and taken as the "maximum bulging" moment; and finally, the peak pressure is directly converted into the real-time diameter using the pre-stored "pressure-diameter" table, and the real-time diameter is immediately displayed on the screen.

[0108] The pressure sensor and the display device are integrated according to the "receiving-conversion-display" three modules, and the "pressure-diameter" integration real-time visualization is realized based on the unique stable state (first inflation configuration) of the balloon body 20, which has the following significant advantages:

[0109] Firstly, the diameter of the balloon body 20 can be obtained by detecting the pressure in the balloon body 20 in real time, avoiding the use of additional displacement or visual sensors. Once the pressure is abnormal (overpressure or loss of pressure), the system can immediately determine that the balloon body 20 is in the non-stable retracted / second inflation state and trigger protection, thereby reducing the risk of bursting or deflation.

[0110] Secondly, only one pressure signal can output "conformation state-time curve" and "diameter-time curve" simultaneously, reducing the type of sensor and wiring complexity, reducing failure rate and cost.

[0111] Thirdly, the display module automatically extracts the inflation pressure peak value, and can evaluate the fatigue degree of the membrane body 22 in combination with historical data to realize preventive maintenance; at the same time, the best working interval can be prompted in real time to prolong the service life of the elastic skeleton 21 and the membrane body 22.

[0112] Fourthly, the operator can directly observe the "pressure-diameter" synchronous curve on the display device to quickly complete pump body calibration and fault positioning; remote data uploading is supported, which is convenient for cloud diagnosis and software upgrading.

[0113] In addition, all the above-mentioned functional modules can be integrated in the pump body end cover or control handle, without occupying additional pipeline space, and are particularly suitable for portable or implantable miniature fluid pump 1 applications.

[0114] The working process of the fluid pump 1 will be described in detail below:

[0115] When the entire device enters the working environment, the initial state is that the elastic skeleton 21 is in a completely axially stretched and radially compressed state, and the device and the balloon 4 are empty. After removing the axial stretching factor (which can be a driving assembly capable of providing axial driving force for the valve column 30), the elastic skeleton 21 drives the mold body to gradually restore the spherical shape, the balloon body 20 is under negative pressure, the fluid in the external environment enters the balloon body 20 to make it full, and under the action of the second valve 50, the fluid in the balloon 4 cannot enter the balloon body 20.

[0116] Then, the balloon body 20 is axially compressed, and under the action of the first valve 40, the fluid in the balloon body 20 cannot flow into the external environment, but flows into the balloon 4.

[0117] After removing the axial compression factor, the balloon body 20 restores the spherical shape, the balloon body 20 is under negative pressure, the fluid in the balloon 4 cannot return to the balloon body 20, and the fluid in the external environment enters the balloon body 20 to make it full.

[0118] After repeatedly removing the axial compression factor and then axially compressing the balloon body 20, the fluid in the external environment can continuously pump into the balloon 4 through the balloon body 20 and make it enter the working state.

[0119] Finally, after removing the axial compression factor, the balloon body 20 skeleton is further completely axially stretched (i.e. the balloon body 20 is radially compressed), the fluid in the balloon 4 and the fluid in the balloon body 20 flow into the external environment through the discharge port 11 of the connecting piece 10, so that the entire device and the balloon 4 are empty again, and the initial state is restored. At this time, the device can end the work and be taken out of the working environment.

[0120] After removing the completely axial stretching factor, the balloon body 20 can again enter the working state.

[0121] The fluid pump 1 with the above setting mode can directly enter the laparoscope channel and has the function of the fluid pump 1. By integrating the two actions of “pumping in” and “emptying” fluid, and only one external control instrument is needed to control the two actions, the operation is simple, and the fluid in the external environment can be continuously pumped into the balloon 4 through the capsule 20 and put into working condition without relying on an external pump. When the device is applied to laparoscopic (including robotic) surgery, there is no need to connect an extension tube, and space and operation channels are saved under laparoscopy. More importantly, the application of the device can reduce trauma and be more minimally invasive.

[0122] Specifically, the device can expand the application range of interventional balloons, especially vascular balloons. Originally, the vascular balloons were inserted into the blood vessels for occlusion or dragging through percutaneous puncture intervention, and then combined with laparoscopic surgery. After the combination of the device, the vascular balloons are directly inserted into the blood vessels for occlusion or dragging through the laparoscopic channel. In this way, the percutaneous puncture trauma is reduced, the operation time is reduced, and the related complications such as thrombosis are reduced, and the trauma is more minimal.

[0123] At the same time, the fluid pump 1 with the above setting mode can change the existing laparoscopic vascular surgery method to a certain extent. If the balloon occlusion and dragging are performed when the original III to IV grade inferior vena cava embolus is removed, the balloon instrument must be inserted through percutaneous puncture in advance. After the combination of the fluid pump 1 and the vascular balloon, the whole operation can be completed by laparoscopy or robot. In addition, the fluid pump 1 can be combined with other working elements and applied in laparoscopic or robotic surgery, such as space expansion devices. In this way, many bottleneck problems in laparoscopic or robotic surgery can be solved.

[0124] The medical device provided in the present application includes the vascular occlusion and shunt device described in the above specific embodiments. Other parts of the medical device can refer to related technologies, which will not be expanded herein.

[0125] It should be noted that in the present specification, the relationship terms such as first and second are only used to distinguish one entity from another entity, and do not necessarily require or imply any such actual relationship or order between the entities.

[0126] The above describes the vascular occlusion and shunt device and the medical device provided in the present application in detail. The principles and implementation modes of the present application are described by applying specific examples, and the above description of the embodiments is only used to help understand the scheme and core idea of the present application. It should be pointed out that for ordinary skilled persons in the technical field, some improvements and modifications can be made to the present application without departing from the principles of the present application, and these improvements and modifications also fall within the protection scope of the present application.

Claims

1. A vascular occlusion and bypass device, comprising: The application relates to a blood vessel obstruction removal device, which comprises the following components: a catheter, which is arranged to be inserted into two incisions of a blood vessel and to communicate blood between the two incisions; a blocking member, which is arranged on the catheter and is used to block the catheter in a first state and open the catheter in a second state; an inflatable balloon, which is arranged on both ends of the catheter and is used to be inserted into the blood vessel through the incisions, fix the catheter in the blood vessel and remove the obstruction from the blood vessel; and a fluid pump, which is connected with the balloon and is used to inject fluid into the balloon to make the balloon in a preset inflation state. The blocking member comprises a blocking body, which is provided with a through hole for the catheter to pass through, and the blocking body comprises a rigid side wall and an elastic side wall, and when the elastic side wall is attached to the rigid side wall, the blocking member blocks the catheter. The blocking member further comprises a connecting structure, which is arranged on the outer wall of the rigid side wall and the elastic side wall, and the connecting structure is used to connect an operating instrument, the operating instrument acts on the elastic side wall and the rigid side wall to make the blocking member switch from the first state to the second state. The connecting structure is a connecting lug, which forms a lug hole with the outer wall of the elastic side wall or the rigid side wall and is used for the operating instrument to extend into. Both ends of the catheter are provided with elastic sections, and a spiral spring skeleton is embedded in the tube wall of the elastic sections to prevent the catheter from being bent and blocked at the incisions of the blood vessel.

2. The vascular closure and bypass device of claim 1, wherein, The outer surface of the balloon in the inflation state is in a stepped shape, the balloon comprises an integral cylindrical fixing part and a tapered scraping part, the taper angle of the tapered scraping part is 15-45 DEG, and the tapered scraping part is used to contact and scrape off the obstruction on the inner wall of the blood vessel.

3. The vascular closure and bypass device of claim 2, wherein, The fluid pump comprises:

4. The vascular closure and bypass device of claim 3, wherein, a connecting member, which is connected with the balloon; 5. The vascular closure and bypass device of claim 1, wherein, a balloon body, one end of which is connected with the connecting member and is used to switch between a retraction structure, a first inflation structure and a second inflation structure; 6. The vascular closure and bypass device of claim 1, wherein, a valve column, which is movably embedded in the connecting member, two ends of the valve column are connected with a first valve and a second valve respectively, the other end of the balloon body is connected with the first valve, and the valve column is configured to switch the balloon body from the retraction structure to the first inflation structure in a first moving stage to guide external fluid into the balloon body through the first valve, and switch the balloon body from the first inflation structure to the second inflation structure in a second moving stage to inject the fluid in the balloon body into the balloon through the valve column, the second valve and the connecting member.

7. The vascular closure and bypass device of any one of claims 1-6, wherein, The connecting member is provided with a discharge port, the valve column is configured to close the discharge port at the end of the first moving stage and the second moving stage, and open the discharge port to discharge the fluid in the balloon body and the balloon from the discharge port when the valve column is separated from the connecting member. The balloon body comprises an elastic skeleton and a membrane arranged on the elastic skeleton, the elastic skeleton is connected with the connecting member and the first valve, the membrane is used to deform under the drive of the elastic skeleton, and the elastic skeleton comprises: a first connecting ring, which is fixed to the connecting member; a second connecting ring, which is fixed to the first valve; 8. The vascular closure and bypass device of claim 7, wherein, ​ 9. The vascular closure and bypass device of claim 7, wherein, ​ ​ ​ A plurality of elastic arms are arranged between the first connecting ring and the second connecting ring in a circumferential direction, for providing an elastic force to the membrane body, so that the capsule body has a tendency to switch from the retracted configuration to the first inflated configuration, or from the second inflated configuration to the first inflated configuration.

10. A medical device, characterized by The blood vessel occlusion and bypass device comprises the blood vessel occlusion and bypass device according to any one of claims 1-9.

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